FDA to scrutinize tobacco Industry

One in five of about 46 million people smoke in the United States. About 3% of American adults use smokeless tobacco. Tobacco used in the U.S. causes about 443,000 deaths per year according to the U.S. Centers for Disease Control and Prevention (CDC). Every year about 230 new tobacco products are launched by the companies and many existing products are changed to increase the addiction/ sales of the products. Now U.S. Food and Drug Administration (FDA) has taken a lead to scrutinize the tobacco industry and issued guidelines to the tobacco industry outlining how to apply for review.

The FDA has issued guidelines that certain tobacco products introduced or amended after Feb. 15, 2007 must be reviewed by the agency. The companies marketing tobacco products must prove that the products are “substantially equivalent” to products commercially available on Feb. 15, 2007.

Those who don’t know the terminology “substantially equivalent”, it means the products must be the same in terms of ingredients, design, composition, heating source and other characteristics to an existing, single predicate product or have different characteristics, but not raise different questions of public health.

Tobacco manufacturers must apply for the review of their tobacco product introduced or changed after Feb. 15, 2007 to continue to sell the products in the market.

Manufacturers who are planning to introduce a new product must apply for a marketing order from the FDA before launching of the product.

Tobacco products that don’t meet those criteria will have to be withdrawn from the market

“Up till now tobacco products had been the only mass-consumed products for which users do not know what they’re consuming,” Dr. Lawrence Deyton, director of the FDA’s Center for Tobacco Products, said in a conference call. “No longer will changes to products consumed by millions of Americans be made without anyone knowing.”

The guidelines talk about new products or altered products that were introduced after Feb 15, 2007, however, it is not clear how these regulation will affect major tobacco companies such as Altria Group Inc. (MO), the parent...

company of Philip Morris USA; Reynolds American Inc. (RAI); and Lorillard Inc. (LO). All of these companies have been marketing cigarettes for decades, as well as smokeless or chewing tobacco brands that have also been on the market prior to 2007.

The 2009 tobacco control act allows the FDA to regulate tobacco products and reduce their nicotine content, regulate marketing, and prohibit label claims such as “low tar” and “light.”

Besides the recent guidelines, FDA has also proposed graphic Health Warnings for Cigarette packages and advertisements. The final regulation requires these color graphics to be issued by June 22, 2011. Here are the links of color graphics proposed by the FDA.

No known tobacco product is safe for consumption. There are many young children who become addicted to smoking and other tobacco products without knowing their dangerous effects on the body. I am pleased that FDA has taken a step to keep control on the tobacco industry and proposed some warning pictures to put on the packets. Having such nasty pictures should provoke many people to discontinue tobacco products.